EU Up to date EU legal situation

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Papa Lazarou

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This is a typo:
".....or whose intended use results in a mean maximum peak plasma concentration exceeding 4 mg per ml."

It should read 4ng/ml (4 nanogrammes). At 4mg/ml (4 milligrammes) some but not possibly not all people would be dead (some have extreme tolerance to nicotine). My maths is a bit weak but I think this is 4,000 times the level they meant to say.

A heavy vegetarian diet might get you up to 4ng, although 2ng/ml is the normal background noise from the diet (nicotine in vegetables, tea etc.). A vaper often reads about 15ng to 20ng, smokers can measure as high as 30ng although many are down around 15ng where many vapers are. In the past, when cigarettes were stronger, 50ng or even 60ng was reported.

A nanogram (ng) is one millionth of a mg. It's clearly an error as 4mg/ml in blood would be like having weak e-liquid for blood :D Anyone would be dead from that. The actual level in the EU proposal is 4ng/ml, but to me this is kind of irrelevent. Wasn't there some study carried out a long time ago that showed "18mg" e-cigs didn't reliably raise blood plasma concentrations of nicotine above the background level? Yet when they tested people who were using them properly they reliably achieved plasma levels of 20ng/ml+. This suggests the results can easily be fudged depending on what the body carrying out the test is trying to prove.

The gotcha's here are the proposed limits of 4mg/ml and no package sizes containing more than 2mg. So effectively this will outlaw bottled e-liquid. A typical cartomizer with a 1ml capacity will be limited to being sold with 2mg/ml liquid, or alternatively a small 0.5ml cartridge could contain 4mg/ml liquid. It's a de facto ban as these levels will render e-cigs without a medical authorisation (which presumably will be allowed in proper strengths) totally ineffective.
 

Vocalek

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Absolutely correct Papa Lazarou.

It's possible that the EU misunderstands how e-cigarettes work. They may be thinking that the cartridge that looks like a cigarette filter is the equivalent of one smoked cigarette, or one serving of a pharmaceutical nicotine product.. Nicotine gum and lozenges contain dosages of either 2 mg or 4 mg. The recommendation is to use 10 to 12 servings per day.

But even a small cartridge contains a vapor capacity of 100 to 150 puffs, which takes the same amount of time to consume as 10 to 15 cigarettes. Dr. Polosa's pilot study used cartridges with a capacity of about 1/3 mil and each cartridge contained 7.2 ml of liquid. The peak number of cartridges used per day for those who quit smoking was about 3 per day at week 4, dropping to 2 per day at week 12 through week 24.

BMC Public Health | Full text | Effect of an Electronic Nicotine Delivery Device (e-Cigarette) on Smoking Reduction and Cessation: A Prospective 6-Month Pilot Study

So at peak levels, Dr. Polosa's subjects would have been taking in 21.6 mg per day in nicotine, leveling off to 14.4 to maintain smoking abstinence and prevent relapse. To match this using 2 mg. cartridges, the subjects would have needed to use 10.8 cartridges per day at week 4, and leveled off at 7.2 cartridges per day to maintain smoking abstinence. That's a lot of puffs, ranging from a low of 100 * 7.2 = 720 puffs / day to 150 * 10.8 = 1620 puffs per day.

Someone smoking a pack a day of tobacco cigarettes would take 200 puffs a day. So at the high side, those who switch to 2 mg. cartridges would need to puff the equivalent of over 8 packs of cigarettes a day. Assuming 8 hours of sleep and awake 16 hours per day, it would require 101.25 puffs per hour to accumulate 1620 puffs, and they would need to be taking a puff every 3.5 seconds.

Bullen, et al, published "Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial "

Results Over 60 min, participants using 16 mg ENDD recorded 0.82 units less desire to smoke than the placebo ENDD (p=0.006). No difference in desire to smoke was found between 16 mg ENDD and inhalator. ENDDs were more pleasant to use than inhalator (p=0.016) and produced less irritation of mouth and throat (p<0.001). On average, the ENDD increased serum nicotine to a peak of 1.3 mg/ml* in 19.6 min, the inhalator to 2.1 ng/ml in 32 min and cigarettes to 13.4 ng/ml in 14.3 min.
Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial -- Bullen et al. 19 (2): 98 -- Tobacco Control

* This is probably a typo, should read 1.3 ng/ml.

At only 2 mg / cartridge, Bullen's subjects would have needed to consume 8 cartridges per day, which equates to 800 to 1200 puffs / 16-hour day (or 50 to 75 puffs per hour -- one every 7.2 to 4.2 seconds.

If you ask me, that's one heck of a lot of puffing, making talking, eating, and taking care of bodily functions rather difficult to accomplish.

If we work the math in the other direction and assume that Bullen's subjects would take the same number of puffs from a 2 mg. cartridge as the actual subjects did, the peak level achieved would be only one eighth of the level as using a 16 mg. cartridge--0.15 ng/ml.
 
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MarVp

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Absolutely correct Papa Lazarou.

It's possible that the EU misunderstands how e-cigarettes work. They may be thinking that the cartridge that looks like a cigarette filter is the equivalent of one smoked cigarette, or one serving of a pharmaceutical nicotine product.. Nicotine gum and lozenges contain dosages of either 2 mg or 4 mg. The recommendation is to use 10 to 12 servings per day.

Yes, I believe they have been plucking "plausable" figures out of the air. Now just waiting for the explanation to come that their reasoning is that 'it is the same levels their gum contains'. It would convince most people who otherwise would have no understanding of the mechanics in this area.
 
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Papa Lazarou

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Yes, I believe they have been plucking "plausable" figures out of the air. Now just waiting for the explanation to come that their reasoning is that 'it is the same levels their gum contains'. It would convince most people who otherwise would have no understanding of the mechanics in this area.

The EU said:
The nicotine threshold identified in this proposal has been established by considering the nicotine content of medicinal products (Nicotine Replacement Therapies, NRTs) for smoking cessation which have already received a market authorisation under the medicinal products' legislation. The proposal removes current legislative divergence between Member States and the differential treatment between Nicotine Replacement Therapies and Nicotine Containing Products, increases legal certainty and consolidates the on-going development in Member States. It also encourages research and innovation in smoking cessation with the aim of maximising health gains. Given the novelty and rapid increase of the NCP market as well as their addictive and toxic character there is an urgency to act, before more people – unaware of the content and effects of these products – inadvertently develop a nicotine addiction.

I believe this means the levels have been set to be below those of NRT products. Effectively this protects the interests of pharmaceutical companies, and other large players able to obtain a market authorisation (which requires a clinically tested product). I don't think many of us here really believe that this is genuinely about "maximising health gains" as they claim. It also ignores the concept of tobacco harm reduction. Snus remains banned across the EU, despite huge evidence showing improved safety compared to cigarettes which will remain available. Almost certainly it will mean a lot of e-cig users in the EU going back to smoking, quite possibly smoking cheap counterfeit Chinese cigs.

As for people "inadvertently developing a nicotine addiction" because they are unaware of the content of the products, that is a ridiculous straw man argument. It's a problem that simply doesn't exist except in the imagination of the EU bureaucrats.
 
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TrueNews

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Its obvious that they have chosen the 4mg figure so it "looks" like they are being even handed with the BP industry who have their strongest gums quoting that number. In reality, most people might use a fraction of a ml in a sitting with their e-cig, and with inefficiencies, that equates to no-where near the nicotine absorption they might get from having a combustible cigarette (or the gum), rendering the e-cig ineffective (no threat) to the two main players (BT and BP).

Looking at the figures they quote more rationally (big benefit of the doubt!), I believe they would be referring to the nicotine concentration when in the gaseous form, i.e how it is when presented to your body as a vapor. Not sure how much a ml of gas is, but if it had a 4mg concentration of nicotine I suspect you could get those 4mg/ml plasma levels they also quote!

Am I correct in assuming that the only true way to ascertain nicotine absortion is by measuring cotinine levels ?

If so where do the following fit in:
1. 15 mg Nicorette Inhalator
2. 21mg Nicorette Patch

How do they differ from the (OLD) 8mg cigarette, which now appears to be the (NEW) 0.7mg cigarette - the 'mg' figures appear to be designed to confuse any layman.

18mg fluid at 10% absorbtion is only 1.8mg - but which figure do we use and can we prove the absorbtion levels for E-Cigs yet ?
 
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TrueNews

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Quote Originally Posted by MarVp - On another tangent... I'd love to know what the mg/ml concentration of the BP inhalers are. I remember reading they contain in the order of 15mg of nicotine, and I believe their liquid content would be quite low. If it comes to it, roll on the "MOD" industry in the EU, devising a porous plug of polyethylene to contain 2mg of nicotine and a separate flavoring capsual. The porous plug needs to get replaced every half hour or so.

Check out the new Pyruvic Acid (Batteryless) Inhaler/Ecig being developed by Duke University MarVp.
It looks like it might use liquid nicotine to create real 'vapor'.
 
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Rcun

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voiceoverip

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Hey update from France:

Government is planning a law to be voted in June/July, limiting sales to 18+ years old, probably no vaping in public places and reinstating a nicotine limit, probably still 20mg/ml.

Unfortunately the French media are preparing the general public in order to limit ecig sales to pharmacies, it seems all TV/Radio appearances of the ecig are controlled by big pharma who always send their key expert. His prime argument is children who could be made nicotine dependent with ecigs. Funnily enough all brick and mortar shops show a -18 sign on their door, and most webshops do the same.

There is a French association for ecig: www.aiduce.fr with about 10K petition signatures for the moment.

The current hard economic crisis in France and the lack of governement initiative to solve budget deficits added to the loss of tax revenue generated by ecigs (cigarettes are taxed highly, 80% of the retail price are taxes in France) combined with big pharma pressure unfortunately wiegh very negatively on ecigs future.
 

pmos69

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Draft opinion on the proposed TPD from the JURI committee (Legal Affairs)
They recommend taking e-cigs out of the proposal completely.

http://www.europarl.europa.eu/sides.../NONSGML+COMPARL+PE-510.591+01+DOC+PDF+V0//EN


By prohibiting any labelling that suggests that a particular tobacco product is less harmful than others, the proposal causes an additional problem. The development and promotion of less harmful means of tobacco use is essential in order to support tobacco users to stop smoking cigarettes and the like. Manufacturers mustbe able to communicate that a certain product is less harmful than others if this is scientifically proven and if it is not misleading.
This is not the only measure proposed that would make it more difficult to access reduced risk products. Article 18 of the proposal prohibits nicotine-containing products (NCP) such as e-cigarettes containing a certain nicotine level if they are not authorised pursuant to Directive 2001/83/EC (the Medicinal Products Directive). It is, however, quite unclear if these products (which are much less harmful than tobacco products)even fall under the scope of the Medicinal Products Directive.
For products which do not fall under the Directive, this wouldeffectively constitute a ban. Banning products which are less harmful than tobacco productsand which can be a means of smoking cessation is certainly not in line with the public healthaims of the proposal.

This is in-line with the opinions of several member state parliaments, in aspects like the subsidiarity principle.
 
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